Kornimate/medical-research-clean huggingface dataset:
venous insufficiency and neuromuscular stimulation

Conditions: Chronic Venous Disease; Venous Insufficiency; Deep Venous Obstruction

Summary: the investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

study aims 1. to obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest. 2. to ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life. methods controlled interventional trial. group 1 (10 subjects) will be healthy subjects with no clinical venous disease. subjects with venous incompetence to be recruited into one of three groups. group 2 (10 subjects) will have superficial venous incompetence; group 3 (10 subjects) will have deep venous incompetence; group 4 (10 subjects) will have deep vein occlusion. these will be clinical diagnoses confirmed with duplex ultrasound. the device used in this study will be the geko™ t-1 device (firstkind ltd, uk). a geko™ device will be fitted to each leg. the device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground). endpoints primary end-point * increase in venous flow secondary end points * improvement in clinical symptoms at 6 weeks, as judged by questionnaire * reduction in absolute leg diameter and volume at 6 weeks

Eligibility criteria:
group 1 * inclusion criteria - 18+ years old, 17\<bmi\<30 * exclusion criteria - heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous vte, abpi\<0.9, active infection, previous leg fracture or metal implant in leg group 2 * inclusion criteria - 18+ years old, 17\<bmi\<30, clinical diagnosis of superficial venous insufficiency (ceap c2-6) confirmed with duplex us * exclusion criteria - heart/lung/kidney failure, pregnancy, abpi\<0.9, active infection, previous leg fracture or metal implant in leg group 3 * inclusion criteria - 18+ years old, 17\<bmi\<30, clinical diagnosis of deep venous insufficiency (ceap c2-6) confirmed with duplex us * exclusion criteria - heart/lung/kidney failure, pregnancy, abpi\<0.9, active infection, previous leg fracture or metal implant in leg group 4 * inclusion criteria - 18+ years old, 17\<bmi\<30, clinical diagnosis of deep venous obstruction confirmed with duplex us * exclusion criteria - heart/lung/kidney failure, pregnancy, abpi\<0.9, active infection, previous leg fracture or metal implant in leg

Keywords: deep venous obstruction venous insufficiency
hemodynamic efficiency of an hemodialysis treatment with high permeability in post-resuscitation shock

Conditions: Cardiac Arrest; Sudden Cardiac Death; Shock

Summary: rationale: despite spontaneous cardiac activity recovery, a shock occurs in more than half of patients after resuscitation for cardiac arrest. this acute circulatory insufficiency presents similar characteristics with septic shock and is responsible of most early deaths. most frequently, usual treatments are unable to control this shock and to avoid the appearance of multiple organ failure. aim of the study: in addition to conventional therapeutics, an early plasma epuration of inflammatory mediators (hdhp) could be able to improve hemodynamic parameters and to reduce the shock duration. this improvement could have an impact on multiple organ dysfunctions and also on early mortality.

hdhp (plasma epuration of inflammatory mediators) will be used in addition to the current clinical practice. the experimental arm will be treated by hdhp device. the high permeability membrane septex is a membrane polyarylethersulfone sold by gambro that allows the purification of molecules of average size to near 50 kd molecular weight. we can thus purify molecules larger molecular weight than hemofiltration can with the usual membranes (30 kd). furthermore, this increase in permeability allows a significant treatment medium-sized molecules in diffusion (hemodialysis), that the usual membranes do not allow. finally, it is possible to purify certain molecules that hemofiltration including high volume does not allow (tnfalpha for example). use of this membrane requires the use of specific set dedicated machine prismaflex itself with a specific software (exceed) to ensure the control and security of processing. 2 sessions of hdhp will be performed in the first 48 hours following icu admission (with inclusion in the first 8 hours).

Eligibility criteria:
inclusion criteria * comatous patients admitted to the icu for a sudden cardiac death apparently related to heart disease and requiring catecholamine infusion to treat a shock * cardiac arrest in front of witnesses * written informed consent obtained from the family or by emergency procedure exclusion criteria * age under 18 years * response to verbal commands (glasgow score \>7) * terminal illness present before the cardiac arrest * acquired or innate immune deficit * anticoagulation not recommended or high hemorrhagic risk * pregnancy * weight \> 100 kg * without social security * another clinical trial ongoing * cardiac arrest from non cardiac etiology

Keywords: plasma epuration hemofiltration cardiac arrest shock inflammatory mediators
the value of repeated biomarker measurements during an sbt to predict extubation failure in icu patients

Conditions: Weaning Failure; Mechanical Ventilation; Spontaneous Breathing Trial; Extubation Failure

Summary: the value of repeated biomarker measurements during an sbt to predict extubation failure in mechanically ventilated icu patients

rationale: in order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in icu care. currently, clinical criteria and spontaneous breathing trials (sbts) are used to assess readiness for extubation. data on the prognostic value of biomarkers in this setting are limited. objective: to investigate the association of biomarker measurements (nt-probnp, hstroponin-t, ckmb, myoglobin, gdf-15, crp, il-6, pct, cystatin-c, ca-125, galectin-3, st-2, albumin) during an sbt with extubation failure in mechanically ventilated icu patients. study design: multi-centre prospective observational cohort study. study population: adult icu patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria. main study parameters/endpoints: extubation failure (the need for reintubation within 7-days). nature and extent of the burden and risks associated with participation, benefit and group relatedness: this study will collect data that is clinically available, but also encompasses repeated biomarker measurements, cardiopulmonary echographic examination and electrocardiography. because almost all mechanically ventilated icu patients have an arterial line, blood can be easily sampled without venepuncture and poses negligible risks for the study patients.

Eligibility criteria:
inclusion criteria: * aged ≥18 years * mechanically ventilated for more than 48 hours * fulfilling readiness-to wean criteria * written informed consent from the patient or his/her legal representative exclusion criteria: * patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment) * planned replacement of the endotracheal tube for a tracheostomy * terminal illness
understanding communications included with covid-19 (corona virus disease of 2019) home testing kits

Conditions: COVID-19 Testing; Decision Making

Summary: to test competing sets of information for consumers on how to interpret hypothetical sars-cov-2 home test kit results and whether they report plans to take cdc-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. participants will be randomized to receive either information from the fda authorized ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive covid-19 test (usual care) or a decision science-based design of similar length (intervention).

to test competing sets of information for consumers on how to interpret hypothetical sars-cov-2 home test kit results and whether they report plans to take cdc \[centers for disease control\]-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. participants will be randomized to receive either information from the fda authorized ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive covid-19 test (usual care) or a decision science-based design of similar length (intervention). participants will be randomized to receive either information from the fda authorized ellume home test kit for what actions to take for a negative or positive covid-19 test (usual care) or a decision science-based design of similar length (intervention). they will be given time to read the documents and the opportunity to download a full "instructions for use" document (the fda authorized for the ellume test kit). they will then be randomized to one of four conditions, asking them to imagine a clinical context: a person with no symptoms and no close covid-19 contact, no symptoms and close contact,

Eligibility criteria:
inclusion criteria: * participants must be \>18 years old, communicate in english, reside in the united states. exclusion criteria: * respondents who complete the survey in under a minute.
a safety and tolerability study of abt-126 in elderly

Conditions: Alzheimer's Disease

Summary: the objectives of this study are to assess the safety, tolerability and pharmacokinetics of abt-126 in elderly subjects.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects 65 years or greater. * has a mmse score of 27 or higher. exclusion criteria: * history of dementia including by not limited to alzheimer's disease, parkinson's disease and mult-infarct dementia. * history of any significant neurological disease. * has an estimated creatinine clearance \< 30 ml/min
short term effect of liraglutide versus vildagliptine on insulin secretion and insulin sensitivity in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this is a single blind randomised controlled clinical trial in uncontrolled type 2 diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic. participants will be randomised in two arms : arm 1 receiving liraglutide at 1,2 mg/day and arm 2 vildagliptine at 100mg/day over 14 days. the two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.

incretinomimetics include exogenous glucagon-like peptide analogs (glp1a) such as liraglutide, and inhibitors of dipeptidyl peptidase iv (dpp4i) that prolong the half-life of endogenous glp1 such as vildagliptin. it remains unclear which of the two strategies (exogenous glp1 or prolonging half-life of endogenous glp1) have better short term effect on insulin sensitivity and insulin secretion in people living with type 2 diabetes. this study aims to investigate the short-term metabolic effects of a glp-1 analog liraglutide versus a dpp4i vildagliptin. it is a randomized, controlled, single-blinded clinical trial. study population consists of uncontrolled type 2 diabetes mellitus patients (hba1c≥7%) under mono or bi oral anti-diabetic therapy, naïve of any incretinomimetic treatment. participants are randomized in 2 arms. the intervention in arm 1 consists of add-on subcutaneous liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week. in the second arm, it consists of oral vildagliptine at 100mg daily for two weeks. the primary outcome is the variation in euglycaemic hyperinsulinaemic clamp-derived insulin sensitivity before randomization and the day after intervention, secondary outcomes include 14-day changes in insulin secretion during a mixed meal tolarance test, body weight and body composition, and an indirect calorimetry measured resting energy expenditure. changes from baseline to 14 days in serum creatinine and alanine amino transferase, c-reactive protein and lipid profile will also be recorded.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus known for at least one year * uncontrolled glycaemic profile with hba1c ≥ 7% on oral antidiabetic mono or bi-therapy * naïve of incretinomimetic treatment * informed consent exclusion criteria: * change in antidiabetic treatment less than 3 months prior to inclusion * pancreatitis * alanine amino transferase \> 3 times the normal values * pregnant or breastfeeding women * estimated glomerular filtration rate \< 60ml/min * infection less than 10 days prior to inclusion or during the study * acute complication of diabetes * total haemoglobin \< 11g/dl in women or \< 13g/dl in men * withdrawal of consent

Keywords: diabetes glp-1 insulin secretion insulin sensitivity africa liraglutide vildaglipin
montelukast in seasonal allergic rhinitis - fall 1999 study (0476a-117)

Conditions: Seasonal Allergic Rhinitis

Summary: this study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.


Eligibility criteria:
inclusion criteria: * patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season * patient is a nonsmoker * patient is in good general health exclusion criteria: * patient is hospitalized * patient is a woman who is less than 8 weeks postpartum or is breast-feeding * patient intends to move or vacation away during the study * patient has had any major surgery within 4 weeks of study start * patient is a current or past abuser of alcohol or illicit drugs * patient has been treated in an emergency room for asthma in the past month * patient had an upper respiratory infection with in 3 weeks prior to study start * patient has any active pulmonary disorder other than asthma
s-flex netherlands registry: prospective evaluation of the supraflex family sirolimus-eluting coronary stent system

Conditions: Coronary Artery Disease

Summary: the primary objective of this registry is to evaluate the safety and efficacy of the supraflex family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

to overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (des) with a biodegradable polymer has been designed. the first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. more recently, second generation des have been developed not only to improve long-term des safety but also to facilitate the procedure by using a cobalt-chromium (co-cr) stent platform. co-cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform. the sahajanand medical technologies pvt. ltd. (smt) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a co-cr stent platform. the purpose of this registry is to evaluate the supraflex family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. the patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a patient informed consent form 3. treating physician has electively implanted at least one supraflex family stent as part of the patient's planned clinical care. 4. the patient is willing and able to cooperate with study procedures and required follow up visits exclusion criteria: 1. women with known pregnancy or who are lactating 2. high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 3. currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements 4. planned surgery within 6-month of pci unless dual anti-platelet therapy is maintained throughout the peri-surgical period

Keywords: coronary artery disease sirolimus-eluting stent biodegradable polymers
additive hemostatic efficacy of endoclot after emr or esd in the gastrointestinal tract

Conditions: Colonic Polyp; Colonic Neoplasms; Colonic Dysplasia

Summary: the investigators want to verify in a randomised trial, the effectiveness of endoclottm in preventing post-procedural bleeding after emr (endoscopic mucosal resection) or esd (endoscopic submucosal dissection) for sessile lesions \>20 mm in the right colon


Eligibility criteria:
inclusion criteria: * \>18 years old * lesions suitable for emr or esd * \> 20 mm * site in the right colon exclusion criteria: * severe cardiovascular pathologies * liver and urinary dysfunctions * hematologic diseases * pregnancy and breast feeding * impossible follow-up * platelet and coagulation disorders (plt \ 2) * sensitivity or allergy to the drug
a study of noscapine hcl (cb3304 ) in patients with relapsed or refractory multiple myeloma

Conditions: Refractory Multiple Myeloma

Summary: this is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine hcl in patients with advanced multiple myeloma


Eligibility criteria:
inclusion criteria: * advanced multiple myeloma. * progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (imid), one alkylator, and bortezomib (velcade®). * ecog performance status of either 0 or 1. exclusion criteria: * prior chemotherapy with antimicrotubule agents * metastasis involving the brain or spinal cord * clinically significant lung or heart disease * abnormal electrocardiogram please note that there are additional inclusion and exclusion criteria. the study center will determine if you meet all of the criteria. site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. you can then decide whether or not you wish to participate. if you do not qualify for the trial, site personnel will explain the reasons.

Keywords: refractory multiple myeloma cb3304 noscapine hcl multiple myeloma
effects of zortress® + tacrolimus vs. standard immunosuppression on progression of coronary artery calcifications and bone disease in de novo renal transplant recipients

Conditions: Renal Transplant

Summary: primary objectives: a. to evaluate the effect of zortress® versus standard immunosuppression therapy on progression of cac as evidenced by changes in agatston scores from baseline and at 6, and 12 months in renal transplantation patients. b. to investigate progression of cac in patients undergoing renal transplantation within the study period. secondary objectives: 1. to evaluate in renal transplantation the effect of zortress® versus standard immunosuppression therapy on bone mass as evidenced by changes in quantitative computed tomography (qct) and dual energy x-ray absorptiometry (dxa). 2. to evaluate in renal transplantation the effect of zortress® versus standard immunosuppression therapy on activity of bone forming and resorbing cells as evidenced by changes in bone histology. 3. to evaluate in renal transplantation the effect of zortress® versus standard immunosuppression therapy on biochemical parameters of bone turnover as evidenced by changes in serum parathyroid hormone (pth), bone-specific alkaline phosphatase (bsap), tartrate-resistant acid phosphatase (trap), sclerostin, receptor activator of nuclear factor kappa b ligand (rankl), osteoprotegerin (opg), , serum ctx (c-terminal telopeptide of type 1 collagen), and urinary ntx (n-terminal cross link telopeptide). 4. to evaluate in renal transplantation the effect of zortress® versus standard immunosuppression therapy on cardiovascular events, graft rejection and patient survival.


Eligibility criteria:
inclusion criteria: * de novo renal transplant recipients (from deceased or living donors) between 18-70 years of age * willingness to participate in the study and comply with study requirements as evidenced by signed irb-approved informed consent enrollment exclusion criteria: * previous solid organ transplant * known hypersensitivity to any of the study drugs, or their class, or to any of their excipients * recipients of an investigational drug within 30 days before transplant * any abnormal physical or laboratory findings of clinical significance which would interfere with conduct of the study * females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or unwilling to use medically approved means of contraception randomization exclusion criteria: * platelet count \<75,000/mm * white blood cell count of \< 2,000/mm³ * hypercholesterolemia (\>400 mg/dl) or hypertriglyceridemia (\>500 mg/dl) despite lipid-lowering therapy * presence of any clinically significant infection requiring iv antibiotics * positive serum hcg (women of childbearing potential) * spot urine protein to creatinine ratio (upr/cr ) ≥ 0.5 * any biopsy-confirmed acute rejection since transplant * baseline cac score \< 100 at baseline reading
a feasibility phase ii study in the treatment of resected cholangiocarcinoma, gallbladder, pancreatic and ampullary cancers

Conditions: Cholangiocarcinoma Cancer; Gallbladder Cancer; Pancreatic Cancer; Ampullary Cancer

Summary: to assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5fu and consolidation gemcitabine/docetaxel chemotherapy.


Eligibility criteria:
inclusion criteria: * patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma. * patients must be 18 years or older. * patients must have a nci ctc performance status of 0-2. * patients must not have any prior chemotherapy or radiation therapy for this current malignancy. * at least 3 weeks should have elapsed since any surgery requiring general anesthesia. * patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for \>5years * pregnant patients are not eligible. non-pregnant status will be determined in all women of childbearing potential. all patients will be required to use an effective means of contraception if sexually active during therapy. * initial required laboratory values: * absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dl. * serum creatinine should be ≤ 2 mg/dl. * serum bilirubin should be ≤ 3.0 mg/dl (biliary stents allowed). * serum transaminases should be ≤ 5-fold the institutional upper limits. * patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection. * patients must be able to sign an informed consent. exclusion criteria: * none

Keywords: cholangiocarcinoma gallbladder pancreatic ampullary cancer